13 results
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23ms
·
Sources: EU EUDAMED, US FDA
PYTON
FDA 510(k)
FDA Class 2
·Anesthesiology
SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CARIES DETECTOR
FDA 510(k)
FDA Class 2
·Dental
VASOVIEW 6 ACCESSORY PACK
FDA Adverse Event
Malfunction
·MAQUET CV·Product code GCJ·January 10, 2019
VASOVIEW 6 ACCESSORY PACK
FDA Adverse Event
Malfunction
·MAQUET CV·Product code GCJ·January 10, 2019
VASOVIEW 6 ACCESSORY PACK
FDA Adverse Event
Malfunction
·MAQUET CV·Product code GCJ·January 10, 2019
Kit BD Max CT/GC/TV; Catalog # 442970
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·August 28, 2019
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 5, 2011
PULSE GEN MODEL 103
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·May 3, 2013
HEARTSTART XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 8, 2014
MLRY-HD LAT POR FMRL 11X160MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·May 13, 2019
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015